RISE 193.121Recalls & reported problems
Globus Medical, Inc. · RISE Spacer 10x22mm, 8-14mm, 10° · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889095213560), received between May 20, 2021 and Feb 29, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
- Migration1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT WAS 8 MONTHS POST-OP FROM ORIGINAL SURGERY AND IT APPEARS ONE OF THE CAGES COLLAPSED. REMOVAL SURGERY OCCURRED (B)(6) 2017.
Patient problems: Failure of Implant
MAUDE report 18809731 ↗MalfunctionMay 20, 2021Loose or Intermittent Connection; Migration
IT WAS REPORTED FROM A REPRESENTATIVE FROM JAPAN THAT A REVISION SURGERY WAS DONE FOR A RISE SPACER WHICH MIGRATED POST-OPERATIVELY WITH SUBSEQUENT SCREW LOOSENING, CAUSING PATIENT PAIN.
Patient problems: Pain
MAUDE report 11859461 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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